Applying GAMP® Concepts to Machine Learning
Cover: This article explores life-cycle activities for machine learning (ML) within regulated life sciences. It positions and contextualizes the life cycle and management of the machine learning subsystem or components within a wider system life cycle. It also gives general descriptions and guidance illustrated by a case study demonstrating a machine learning application to medical image recognition, or software as a medical device (SaMD).
The Road to Explainable AI in GXP-Regulated Areas
Feature: Recent advances in artificial intelligence (AI) have led to its widespread industrial adoption, with machine learning (ML) algorithms demonstrating advances in performance in a wide range of tasks. However, this comes with an ever-increasing complexity of the algorithms used, rendering such systems more difficult to explain. AI developments offer a solution: Explainable AI (xAI): i.e., additional modules on top of the AI core solution that are designed to explain the results to a human audience.
What You Need to Know About GAMP® 5 Guide, 2nd Edition
Feature: ISPE’s GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) (GAMP® 5 Guide, 2nd Edition) maintains the principles and framework of the first edition and updates their application in the modern world, including the increased importance of service providers, evolving approaches to software development, and expanded use of software tools and automation. The 2nd Edition highlights the use of critical thinking by knowledgeable and experienced subject matter experts (SMEs) to define appropriate approaches.
Rapid Filter or Resin Change Strategies for Biomanufacturing
Technical: Pandemic-related supply chain shortages have placed constraints on the supply of essential filters and chromatography resins. An agile regulatory pathway to implement alternative filters and resins into manufacturing is necessary to ensure the continued supply of approved biologics. To allow this in the US and potentially globally, the regulatory strategy proposed in this article is to provide an appropriate characterization package to demonstrate that the alternative filter or resin has a low risk to impact product quality in a prior approval supplement (PAS), and later provide at-scale data as part of an annual report or submission at the time of distribution.
Life-Cycle Approach to Cleaning Topical Drug Products
Technical: Topical drug products and cosmetics are often manufactured in the same facility under a unified quality standard that supports the topical drug products’ performance and label claims. Cleaning is an important component of a manufacturing process, and the process life-cycle approach should be followed for cleaning validation.
This article explores the life-cycle approach to cleaning topical drugs and cosmetics with attention to the cleaning design phase and leveraging this information, including lab studies and pilot runs, for qualifying and monitoring the cleaning process.